| Evidence grading
method：
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We will assess the certainty of evidence using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system and classify evidence as to be high, moderate, low, or very low certainty. The starting point for the certainty for RCTs is high, and for observational studies is low. The certainty will be downgraded due to the following five reasons (risk of bias, imprecision, inconsistency, indirectness, and publication bias) and upgraded due to three reasons (large magnitude of an effect, dose-response gradient, and effect of plausible residual confounding). Moreover, the Norms of development and revision for clinical practice guideline of Chinese medicine (Integrative medicine) Grading of evidence quality and recommendation will also be considered to use if the condition is appropriate. |
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Purpose of the guideline：
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Since the outbreak of the coronavirus disease 2019 (COVID-19), as of May 30, 2022, it has swept through 194 countries, resulting in 525 million confirmed cases and 6.28 million deaths. During the COVID-19 epidemic, it has had a major impact on the physical and mental health of the global population, international economic and trade development. WM used a variety of methods in the treatment of COVID-19, such as specific drugs, antiviral drugs, plasma therapy, etc. There were also oxygen therapy and ventilator treatment, which could provide patients with life support, and effectively control and reduce mortality. As a part of traditional and complementary medicine, Traditional Chinese medicine (TCM) was an important factor in preventing and controlling the COVID-19 epidemic in China. As of May 30, 2022, the L-OVE COVID-19 Repository had included 633 primary studies on TCM10. According to the WHO Report on the evaluation of TCM in the treatment of COVID-19, TCM were effectively treat COVID-19, especially for mild and moderate cases. In the face of the severe development of the epidemic, countries have developed CPGs to provide guidance on the treatment of COVID-19. As of December 31, 2020, a total of 92 CPGs have been published worldwide, of which the specific representative and continuously updated CPGs were the World Health Organization (WHO) published a living guideline on drug for COVID-19(10th edition) and the Guidance for Corona Virus Disease 2019 Prevention, Control, Diagnosis and Management (ninth edition) issued by China's National Health Commission (NHC). In addition to the poor overall quality of existing CPGs, CPGs had the following problems. First, from the perspective of clinical application, the participation of TCM has reached more than 90%, and the use of TCM and WM was mixed. However, most of the CPGs simply recommended TCM or WM, so these CPGs were no longer in line with clinical practice. Although some CPGs were combined TCM and W M, they were also recommended independently, and not clear what treatment should be used. Second, the recommendations were not made according to the whole process of disease development, and it was not well applied to patients or doctors.
TCM emphasizes the holistic perspective and treatment based on syndrome differentiation, whereas WM emphasizes reductionism, focusing on recognizing diseases, identifying causes, and developing countermeasures. Therefore, adhering to the holistic integration of TCM and WM instead of the combination of TCM and WM, HIM guideline can be developed eventually by transforming recognized evidence into recommendations. Then the trustworthy guideline of HIM will integrate the most advanced knowledge and technologies in to clinical practice, and further practice HIM in the factual and empirical medicine conditions. Based on the key conceptions of holistic integrative medicine (HIM), the HIM guideline could develop the best state and program for human health maintenance and disease diagnosis and treatment through the joint action of various factors, and mutual integration.
Therefore, it was necessary to develop a high-quality living evidence-based guideline of HIM for COVID-19 in line with international standards, to improve the treatment effect and patients' quality of life. The HIM guideline adopted the method of living systematic review to comprehensively compare the difference in the efficacy of TCM and WM, followed the treatment principle “if the curative effect of TCM was better, choose TCM, and vice versa”, and made recommendations focused on the diagnosis, prevention, treatment, and rehabilitation of COVID-19 according to the disease course. |
